Biosphere Medical Gains Momentum With Fibroid Treatment After Years of Wait-and-See

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More than a half-million women every year get a treatment for uterine fibroids, or benign tumors in the uterus. Most of the time they get the same thing they would have gotten in the 1970s—a hysterectomy to remove the whole uterus, or a myomectomy to surgically remove the fibroid growth. Biosphere Medical, a Rockland, MA-based company (NASDAQ: BSMD), has been pushing a less-invasive alternative for the past six years, and just may have reached a turning point in getting doctors to accept it.

The company sells a product for what is known as uterine fibroid embolization, which is a procedure that an interventional radiologist uses to cut off blood flow to the fibroids. In August, the procedure was identified as an “A-list” recommendation by the American College of Obstetricians and Gynecologists, after the group spent years cautiously evaluating whether it’s a good idea, says Biosphere CEO Rick Faleschini.

The new approach to treating uterine fibroids is a big shift in treating a common problem. An estimated 5 million women in the U.S., usually between the ages of 25 and 55, have some symptoms of uterine fibroids. They can cause abnormal bleeding, abdominal pain, and lack of bladder control—and it’s severe enough to prompt about 650,000 women to get surgeries to remove them each year, Faleschini says. The number of less-invasive embolization procedures has grown to about 25,000 a year in the U.S., with about 80 percent of this growing market going to Biosphere Medical, most of the rest going to a competing product from Boston Scientific, and about 1-2 percent for a smaller Japanese competitor, Faleschini says.

“Gynecologists are cautious by type,” Faleschini says. “Their first rule is to let something have experience in clinical trials, and prove itself. They want their patients to be loyal to their practice, and gynecologists in the past have adopted technologies too quickly, gotten burned, so now they take a wait-and-see attitude.”

Some of those bad experiences were with synthetic materials under the urethra for incontinence, which led to serious side effects and litigation, Faleschini says. So it was against that backdrop that Biosphere Medical introduced its FDA-approved uterine fibroid treatment in 2002. Biosphere now generates about $30 million in revenue a year as a company, with the vast majority from the uterine fibroid embolization, he says.

Off the bat, this is pretty obviously a hard sell to the gynecologists. They need to refer their patients to an interventional radiologist who does the procedure, so they lose control of the situation. The procedure doesn’t sound like the trickiest in medicine, but it’s not as simple as drawing blood, either.

Here’s how it works. An interventional radiologist punctures the femoral artery in the hip and threads a flexible guide wire inside, Faleschini says. The doctor runs an infusion catheter over the wire, watching on a real-time X-ray monitor where he or she is going, to maneuver inside the uterine artery. Once the catheter is in place, the doctor sees where the fibroids are, and then the company’s proprietary microspheres (polymer beads) are injected to stop the blood flow to the fibroids, which shrinks them over time. The procedure takes the doctor 20 to 40 minutes from start to finish, and the patient goes to a recovery area to rest for eight to 23 hours, but it usually doesn’t involve an overnight stay, Faleschini says.

Biosphere sells the guide wire, microcatheter for infusion, and the microspheres for about $1,500 altogether, Faleschini says.

The key questions for doctors and patients are, how well does it work, and how long does it last? The clinical trials, published in the New England Journal of Medicine, show that the procedure is as effective as surgery at treating symptoms of fibroids, with a lower rate of complications, and with a 10 to 11-day recovery time instead of four to six weeks with surgery, Faleschini says. The treatment doesn’t always last very long, though. About one-fourth of patients who get the embolization have their fibroids come back within five years, Faleschini says.

The results have been good enough to win reimbursement from all major private insurers, Faleschini says. Now the company is starting to tout the recommendation from the gynecologists’ group to win over individual gynecologists, and convince them it’s in their interest to keep their patients happy, and pass them off to an interventional radiologist for this procedure, Faleschini says. “If they fully inform their patients, they will be happy about it, and reward their doctors with loyalty,” Faleschini says.